NCT01659385

Brief Summary

The purpose of this study is to evaluate Leptin levels in females, in the setting of papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2013

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

August 3, 2012

Last Update Submit

August 31, 2023

Conditions

Thyroid Cancer, PapillaryLeptin Levels

Outcome Measures

Primary Outcomes (1)

  • evaluating Leptin level Evaluating Serum Leptin Levels Between 3 Groups. One Group with Papillary Thyroid Carcinoma. One Group With Benign Nodules. One Group with Normal Thyroid.

    Assessing serum leptin levels in females with treated papillary thyroid carcinoma and compared to females with proven benign thyroid nodules and females with normal thyroid glands. All groups were matched by gender, age, and BMI to limit confounders.

    During Study

Eligibility Criteria

Age19 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females with no prior history of thyroid disease and not on thyroid medications. Active recruitment will be for normal controls only. They will be age and weight/height matched to females with prior diagnosis of thyroid cancer or thyroid nodules who are already part of another study.

You may qualify if:

  • Female
  • Age\>/- 19
  • Not currently pregnant or lactating
  • Normal thyroid gland by history

You may not qualify if:

  • Male Gender
  • Pregnancy
  • Lactation
  • Age below 19
  • Abnormal thyroid gland by history
  • Abnormal thyroid gland by structure using ultrasound
  • Abnormal thyroid gland by function using TSH, Free T4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Whitney Goldner, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

August 7, 2012

Primary Completion

April 25, 2013

Study Completion

April 25, 2013

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations

US(1)